A four-year-old ruling by the Pennsylvania Supreme Court is making doctors and researchers across the country change the way they obtain informed consent from patients, according to a panel of experts who spoke at the 2020 virtual Clinical Congress of the American College of Surgeons.
Many physicians, researchers and administrators are concerned that the landmark decision, Shinal v. Toms, leaves them vulnerable to legal action if a physician delegates informed consent to another member of the patient’s care team.
“Lawyers and policymakers are advising an overbroad interpretation of this decision to avoid litigation,” said Valerie Gutmann Koch, JD, the co-director of the Health Law and Policy Institute at the University of Houston, and director of law and ethics at the University of Chicago MacLean Center for Clinical Medical Ethics, during the panel session.
In 2007, Megan Shinal sought the care of Steven Toms, MD, the director of the Department of Neurosurgery at Geisinger Medical Center, in Danville, for treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. Shinal and Toms met to discuss her goals and expectations, and the risks associated with different surgical options, including total and subtotal resections. At their meeting, Shinal did not make a final decision about which surgical approach she wanted.
During a follow-up visit with Toms’ physician assistant, Shinal signed the informed consent form. It did not clearly designate which surgical procedure she preferred.
During her 2008 operation, Toms performed a total resection and perforated Shinal’s carotid artery, resulting in hemorrhage, stroke, brain injury and partial blindness.
Shinal and her husband sued Toms, alleging he failed to obtain her valid informed consent for the procedure. Shinal testified that she would have chosen a subtotal resection as a safer, less aggressive option had she known the alternatives. The jury found that Toms fulfilled his informed consent obligations. However, in June 2017, the Supreme Court of Pennsylvania overturned the decision based on the state’s MCARE Act. The act specifies that, except in emergencies, a physician owes a duty to a patient to obtain their informed consent prior to surgery.
The ruling specifically interprets the Pennsylvania statute and the issue has not been litigated outside of the state. However, Pennsylvania is not the only jurisdiction mandating that the surgeon bear the responsibility of performing informed consent. A similar standard of nondelegation of informed consent might apply in other jurisdictions throughout the country, and it is unclear how such a rule affects residents and fellows in teaching hospitals, Koch said.
The case law on informed consent is limited, Koch explained. The practice of medicine, including informed consent, is governed state-by-state, so the Pennsylvania decision does not necessarily apply in other jurisdictions.
“In truth, what’s happened in reality and on the ground is individuals at every level are worried,” Koch said.
The ramifications continue to reverberate throughout hospitals around the country. Some hospitals have changed their workflow so that as soon as a patient arrives in the emergency department, regardless of their needs, an emergency department physician obtains informed consent for a blood transfusion. This would cover informed consent in case a patient needs a transfusion overnight when residents or other advanced practice providers are managing their care, said Puneet Singh, MD, an assistant professor of surgery at The University of Texas MD Anderson Cancer Center, in Houston.
“This case has dramatically changed and continues to impact care, outside of the operating room and surgeons,” Singh said.
4 Reasons for Concern
The decision is also rippling through the world of clinical research. Koch said institutional review boards now advise clinical trial investigators to alter their consent processes to ensure that physician investigators, instead of recruitment coordinators, secure the consent of participants, she said.
Koch told the virtual congress that the Shinal decision is problematic for four reasons. First, it deemphasizes process by incentivizing a narrower approach to informed consent, focusing on the person conveying the information rather than the information provided to a patient. The decision also prioritizes physician disclosure rather than patient comprehension, she said. She is concerned that the ruling reflects a judicial reaction to the evolving doctor–patient relationship, in which multiple care providers and third parties, such as hospitals and health insurance companies, influence provision of care. Finally, the decision relied on faulty legal reasoning to conclude that a physician cannot rely on a subordinate to disclose the information required for informed consent.
Reimbursement for informed consent may need to be considered if informed consent becomes the physician’s responsibility, Koch said. Payment for time spent obtaining informed consent would “help ensure these discussions to not get delegated to those who are insufficiently trained or not well suited to the task,” Koch said.
The Shinal case should change the way informed consent is taught and obtained at academic centers, said Andrew Redmann, MD, a pediatric otolaryngologist at Children’s Minnesota, in Minneapolis. Historically, informed consent has often been delegated to trainees with minimal oversight from attending surgeons, he said.
However, obtaining informed consent should be considered a learned skill, similar to operative skills, and surgical programs should adopt a system of graduated responsibility, just like for operative skills, to give trainees increasing autonomy with these conversations, Redmann said. “We don’t get a lot of formal training on obtaining informed consent, but it’s incredibly important.”
Redmann said clinincians who are considering delegating informed consent to a trainee must bear in mind three principles: Trainees do not understand the risks of procedures as well as attendings do; if a trainee does not discuss a risk that their attending might have, they are not meeting the standard of care; and the attending surgeon holds primary responsibility for the patient.
“If we remember these three principles, it’s clear that many surgical training programs should critically evaluate the way that they delegate the preoperative informed consent and surgical decision-making process,” Redmann said.
So, Singh recommended a communication approach known as “Best Case/Worst Case,” initially designed for older adults making difficult decisions about surgical procedures as they near the end of life (J Am Geriatr Soc 2015;63[9]:1805-1811). As she sits with a patient, she describes the best, worst and most likely case scenarios.
Singh also recommends that teams revise their workflow for informed consent in light of the Shinal decision. Patients should continue to have repeat interactions with all members of the team, making sure patients understand the risks and benefits of different options. But the surgeon should be the ultimate person who obtains informed consent and has the document signed. “This would allow us to comply with this particular case while still maintaining that rich discussion that occurs with team members and the patient,” she said.
—Christina Frangou
This article is from the May 2021 print issue.